New PARP1 inhibitor targets Hard-to-Treat cancers
NCT ID NCT07695142
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This trial tests an experimental drug called HSK46256, which blocks a protein called PARP1 that helps repair DNA in cancer cells. The study includes adults with advanced solid tumors who have not responded to standard treatments. Researchers aim to find the safest dose and check whether the drug can shrink tumors or slow their growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HSK46256 (a PARP1 inhibitor)
- What this could lead to
- If successful, this could provide a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is an early phase 1 trial, so the drug may not prove safe or effective. Side effects and limited benefit are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 275 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years, voluntarily participate and provide signed informed consent, * ECOG performance status 0-1 or KPS \>60; estimated life expectancy ≥12 weeks, * Histologically or cytologically confirmed locally advanced or metastatic solid tumors, failed prior standard therapy, intolerant to standard therapy, or no available standard therapy, * Dose escalation: prior treatment with one line of non-selective PARP inhibitor allowed, * Documented HRR gene mutation, * Agree to provide tumor tissue and/or blood samples, * Fertile participants must agree to use effective contraception during study and for 3 months after last dose; negative pregnancy test for females, Exclusion Criteria: * Other malignancies within past 2 years (except adequately treated basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma); * Uncontrolled moderate to large pleural, pericardial, or peritoneal effusions; * Prior anticancer therapy or concomitant use of CYP3A4 strong/moderate inhibitors/inducers within protocol-specified washout periods; * Prior anticancer treatment toxicity not resolved to CTCAE ≤Grade 1 (except alopecia, skin toxicity); * Any condition affecting drug swallowing or significantly impacting drug absorption/PK; * Severe or uncontrolled cardiac disease (QTcF prolongation, significant arrhythmia, LVEF \<50%, recent MI/heart failure); * Arterial/venous thromboembolic events within 6 months deemed uncontrolled risk; * Severe/uncontrolled diabetes, hypertension, active bleeding, epilepsy, COPD, interstitial lung disease, active systemic infection; * Unstable systemic disease (severe hepatic/renal/metabolic disorders); * Prior MDS or AML diagnosis, or history of hematopoietic stem cell transplantation; * Major surgery or severe trauma within 4 weeks; * HIV positive, active hepatitis B/C, or active syphilis; * Known hypersensitivity to study drug or excipients; * Participation in another interventional trial within 4 weeks; * Pregnant or lactating women;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
Shanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- Can a radioactive 'Smart Bomb' target tough tumors?
- Can a new pill shrink advanced solid tumors?
- Can a Tumor-Directed injection shrink Hard-to-Treat cancers?
- Can a new gemcitabine formulation outsmart advanced solid tumors?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?